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Senior Statistical Programmer I

2+ years
Not Disclosed
10 Nov. 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior SDTM Programmer

Location: Homebased
Shift: 2pm - 11pm IST


About the Role

ICON plc, a leading global clinical research organization, is seeking a Senior SDTM Programmer to join our team. As the world’s largest and most comprehensive healthcare intelligence organization, ICON partners with pharmaceutical, biotechnology, and medical device companies to help accelerate the development of life-saving treatments.

In this role, you will be responsible for converting raw clinical trial data into Study Data Tabulation Model (SDTM) format, ensuring data consistency and accuracy for regulatory submissions. You will play a critical role in programming clinical reports, developing transfer specifications, and performing quality control checks on programming work to support clinical studies.


Key Responsibilities

  • Clinical Data Programming & Reporting:

    • Extract clinical data from the clinical data management system and generate both standard and custom reports, primarily using SAS.
    • Program reports and listings based on project team requests for ongoing studies.
    • Develop transfer specifications for external data sources and collaborate with vendors for data integration.
  • SDTM Programming & Conversion:

    • Perform programming to convert raw clinical trial data to SDTM format.
    • Conduct consistency checks on data transferred between Incyte and external parties, ensuring the completeness and accuracy of data.
  • Quality Control (QC):

    • Perform quality control on programming work executed by other Database Programmers to ensure the highest quality standards.
  • Automation & Efficiency:

    • Develop and validate global macros or systems to streamline repetitive tasks and enhance programming efficiency.

Qualifications

  • Experience:

    • Minimum of 5 years of clinical SAS programming experience in the pharmaceutical industry.
    • Hands-on experience with SDTM packages, including define.xml, P21, SDRG, Trial Data Domains, and XPT file creation.
  • Technical Expertise:

    • Strong working knowledge of CDISC SDTM mapping, conversion, specifications, and datasets.
    • Experience with eCRF/eCRT package development and SDTM data transfer operations for clinical studies.
  • Regulatory Knowledge:

    • Familiarity with regulatory requirements relevant to clinical study submissions.
  • Skills:

    • Strong communication and interpersonal skills, with the ability to work effectively within a team environment.

Why ICON?

At ICON, we are committed to attracting top talent and fostering a diverse, inclusive workplace. Our people are at the heart of everything we do, and we provide opportunities for professional growth and development. We offer a competitive salary and a comprehensive benefits package that focuses on your well-being and work-life balance.

Benefits include:

  • Annual leave entitlements
  • Health insurance to suit you and your family’s needs
  • Retirement planning offerings to help you plan for your future
  • Global Employee Assistance Programme, providing 24/7 access to a global network of over 80,000 specialized professionals
  • Life assurance coverage
  • Flexible country-specific benefits, including childcare vouchers, gym memberships, travel passes, and health assessments

At ICON, diversity and inclusion are core values. We pride ourselves on creating an environment where employees feel valued and respected. ICON is an equal opportunity employer, and we encourage all qualified individuals to apply, regardless of race, color, religion, gender identity, sexual orientation, disability, or veteran status. If you require any reasonable accommodation during the application process, please let us know.


Interested in this role?

Even if you don’t meet every qualification, we encourage you to apply. You might be exactly what we’re looking for at ICON, whether for this role or other opportunities!